eCRF Plugins: Improved Data Quality in Clinical Trials
Published: 08.16.2021
High-quality data is essential to the success of any clinical trial. Whether in early-phase research or large-scale pivotal trials, the accuracy and completeness of collected data determine how reliable the results are. Alcedis offers a suite of intelligent eCRF Plugins designed to improve data quality, reduce errors, and streamline every step of the data collection process.
These tools are fully integrated into the Alcedis EDC system, helping study teams document, monitor, and verify case report forms (CRFs) more efficiently than ever before. The following Plugins offer practical solutions to the challenges of digital clinical trial documentation.
CRF Status: Real-Time Tracking of Case Report Form Completion
The CRF Status Plugin gives both study sites and project management a quick visual summary of each patient's documentation status in the eCRF system. Once all necessary forms, documents, and data entries are complete for a given case, a green check mark appears.
If there are open queries—either automatically triggered by the system or entered manually—a yellow exclamation mark indicates incomplete or questionable information. Missing forms required for evaluating primary endpoints are highlighted with a red X, showing the site exactly what needs attention.
This Plugin simplifies data cleaning by allowing filtered views of outstanding tasks. Clinical teams can navigate directly to the relevant form, significantly accelerating the collection and validation process. It's a critical component for ensuring that no clinical trial data goes unchecked.
Long free texts, a lack of medication and complicated documentation are common problems in clinical trials. These five plugins from Alcedis help doctors.
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Query Plugin: Simplified Data Review and Communication
The Query Plugin supports structured communication between data managers and sites directly within the eCRF. While most EDC systems support standardized fields, free-text entries still pose challenges for electronic checks—especially when documentation varies in length or structure.
When data cannot be validated electronically, a data manager can raise a manual query within the system using a built-in chat function. Sites can then respond directly in the Plugin, clarify entries, and update the case report form as needed. This interaction ensures that no critical detail is missed and enhances overall clinical data quality.
eSignature Plugin: Secure Electronic Signatures Within the eCRF
The eSignature Plugin allows principal investigators to confirm and sign off on completed eCRFs directly within the EDC system. These digital signatures serve as formal confirmation that the recorded data is accurate and complete for each patient.
Prior to signing, a documentation check ensures that every required form and field has been properly completed. Investigators can view a filtered list of all cases ready for signature—those marked with a green status—ensuring no oversight in the process.
eSignatures not only support regulatory compliance but are also essential for proper site reimbursement. In many clinical trials, signed eCRFs are a prerequisite for invoicing sponsors.
SDV Plugin: Efficient Monitoring Through Source Data Verification
The SDV Plugin (Source Data Verification) enhances monitoring activities by offering a structured comparison between the eCRF data and the original clinical source documentation. For many trials, this verification is required by a CRA (Clinical Research Associate) who visits sites to ensure that reported values match those in the patient records.
The Plugin tracks which forms have been reviewed and whether discrepancies exist. Depending on the study design, the CRA may verify all or only a percentage of the data. Either way, this Plugin provides a clear overview for trial monitors and supports transparent progress tracking.
EVA Plugin: Flexible eCRF Design for Exceptional Cases
With the EVA Plugin (Electronic Validation Acknowledgement), investigators can deactivate certain system checks or mandatory fields in justified cases. For example, if a lab result is missing or a value falls outside the expected range, the physician can override the warning with a documented reason—directly in the form.
This flexibility accelerates workflows and reduces unnecessary queries to the data management team. Still, for critical endpoints and safety-relevant data, such overrides are restricted to ensure the integrity of the clinical research.
Conclusion: Smart eCRF Plugins for Modern Clinical Trial Needs
The Alcedis eCRF Plugins provide advanced, user-friendly solutions that empower sponsors, sites, and research teams to maintain full control over data quality throughout the entire trial lifecycle. Whether you're managing a global clinical trial or a focused academic study, our EDC system and Plugin architecture support efficient form completion, accurate reporting, and smooth collaboration.
From case report form validation to digital signatures and monitoring support—Alcedis delivers the tools needed to modernize and optimize clinical data collection in today’s increasingly complex clinical trials.
Queries or problems often arise during the operational implementation of clinical trials. Plugins developed by Alcedis support users and customers, making their work easier. Find out more about our solutions in the area of user support.